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Ensuring Global Food Safety
This page intentionally left blank
Ensuring Global Food Safety
Exploring Global Harmonization
SECOND EDITION

Edited by
Aleksandra Martinovic
University of Donja Gorica, Centre of Excellence-FoodHub, Podgorica, Montenegro
Sangsuk Oh
Department of Food Science and Technology, Ewha Womans University, Seoul, Korea
Huub Lelieveld
Global Harmonization Initiative (GHI), Vienna, Austria
Academic Press is an imprint of Elsevier
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A catalogue record for this book is available from the British Library
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For information on all Academic Press publications visit our


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Publisher: Charlotte Cockle


Acquisitions Editor: Nancy J. Maragioglio
Editorial Project Manager: Charlotte Rowley
Production Project Manager: Vijayaraj Purushothaman
Cover Designer: Miles Hitchen
Typeset by TNQ Technologies
Contents

List of contributors xv 3. Food regulation around the world


Bernd van der Meulen, Melissa M. Card,
Ahmad Din, Neal D. Fortin, Alida Mahmudova,
1. Introduction: Ensuring global food Bernard Maister, Halide Gökçe Türkoglu,
safety: A public health priority and Fehmi Kerem Bilgin, Joe Lederman,
Margherita Paola Poto, V.D. Sattigeri, MunGi Sohn,
a global responsibility
Juanjuan Sun, Altinay Urazbaeva,
Julie Larson Bricher Yuriy Vasiliev and Rebeca López-Garcı´a
References 3 3.1 Introduction 11
3.1.1 Purpose of this chapter 11
2. Safety and security: the costs and 3.1.2 Food law 11
benefits of traceability and 3.1.3 Framework of analysis 12
transparency in the food chain Further reading 12
3.2 International food law 12
Katy A. Jones 3.2.1 Codex Alimentarius 12
2.1 The burden of foodborne outbreaks 5 3.2.2 Procedural manual 13
2.1.1 Each year 48 million people get 3.2.3 Standards 13
sick from foodborne illnesses, 3.2.4 Codes 13
128,000 are hospitalized, and 3.2.5 Legal force 13
3000 die 5 3.2.6 WTO/SPS 14
2.1.2 About 23% of U.S. food recalls 3.2.7 Conclusion 15
cost the food industry over $30 References 15
million and 14% cost Further reading 15
organizations over $50 million 5 3.3 United States of America 16
2.1.3 Reducing foodborne illnesses by 3.3.1 Introduction 16
just 1% would prevent nearly 3.3.2 The food regulatory system 18
500,000 Americans from getting 3.3.3 Major federal laws 19
sick each year 6 3.3.4 Principles and concepts 20
2.2 The food supply chain: increasing risk 6 3.3.5 Labeling 22
2.3 Working toward traceability and 3.3.6 Conclusion 24
transparency 6 References 25
2.4 The costs associated to a lack of Further reading 25
traceability 7 3.4 Canada 26
2.4.1 Issues with labeling and brand 3.4.1 Introduction 26
claims 7 3.4.2 Institutional 27
2.4.2 Restrictions to market access 7 3.4.3 Principles and concepts 28
2.5 Benefits beyond food safety 8 3.4.4 Authorization requirements 28
2.5.1 Enhanced credibility 8 3.4.5 Food safety limits 30
2.5.2 Transparent marketing 8 3.4.6 Process requirements 30
2.5.3 Increased reliability for 3.4.7 Labeling 31
consumers 8 3.4.8 Human right to food 34
2.6 More operational efficiency 8 References 34
References 8 Further reading 34

v
vi Contents

3.5 The road to harmonization in Latin 3.9.3 Developments 70


America 35 3.9.4 Role of risk analysis 72
3.5.1 Introduction 35 3.9.5 The addressees of food law 72
3.5.2 Steps toward harmonization 36 3.9.6 Codex Alimentarius 73
3.5.3 The challenges of regional food 3.9.7 Institutional 73
regulation 37 3.9.8 Principles and concepts 73
3.5.4 Regional intentions for 3.9.9 Standards 74
improvement: the Pan American 3.9.10 Authorization requirements 74
Commission of Food Safety 3.9.11 Food safety limits 74
(COPAIA 7) 38 3.9.12 Process requirements 74
3.5.5 General regulatory structure 38 3.9.13 Labeling 74
3.5.6 Trade agreements 38 References 74
3.5.7 Conclusions 40 Further reading 75
References 41 3.10 Australia and New Zealand 75
Further reading 41 3.10.1 Introduction 75
3.6 European Union 41 3.10.2 Institutional framework 77
3.6.1 Introduction 41 3.10.3 Principles and concepts 79
3.6.2 Institutional 42 3.10.4 Standards 79
3.6.3 Enforcement and incident 3.10.5 Authorization requirements 80
management 42 3.10.6 Food safety limits 81
3.6.4 Principles and concepts 42 3.10.7 Process requirements 82
3.6.5 Standards 43 3.10.8 Labeling 83
3.6.6 Authorization requirements 43 3.10.9 Human right to food/food
3.6.7 Food safety limits 44 security 85
3.6.8 Process requirements 44 3.11 People’s Republic of China 86
3.6.9 Labeling 44 3.11.1 Concepts, principles, and
3.6.10 Human right to food/food background 86
security 44 3.11.2 Food safety legislative
References 45 framework 87
Further reading 46 3.11.3 Food safety regulatory system 88
3.7 Turkey 46 3.11.4 Conclusion 89
3.7.1 Introduction 46 Further reading 89
3.7.2 Fundamental institutional 3.12 Republic of Korea 90
framework 51 3.12.1 Introduction 90
3.7.3 Standards 52 3.12.2 Competent authorities 91
3.7.4 Authorization requirements 53 3.12.3 Recent harmonization and
3.7.5 Food safety limits 54 modernization efforts 93
3.7.6 Process requirements 55 3.12.4 Food safety regulatory
3.7.7 Labeling 56 approaches 95
3.7.8 Conclusion 57 3.12.5 National surveillance and risk
References 58 assessment activities 97
3.8 The Russian Federation 61 3.12.6 Conclusion 97
3.8.1 Russian food law 61 References 98
3.8.2 Institutions 61 Further reading 98
3.8.3 Technical regulation 61 3.13 Japan 98
3.8.4 General food safety 62 3.13.1 Introduction 98
3.8.5 Authorization 63 3.13.2 Competent authorities 99
3.8.6 Process requirements 64 3.13.3 Conclusion 101
3.8.7 Labeling 65 Further reading 101
3.8.8 Developments 67 3.14 India 102
Further reading 69 3.14.1 Introduction 102
3.9 Azerbaijan 69 3.14.2 Institutional 103
3.9.1 Introduction 69 3.14.3 Principles and concepts 104
3.9.2 Most important sources of 3.14.4 Standards 105
legislation for food 70 3.14.5 Role of Codex in standards 106
Contents vii

3.14.6 Authorization requirements 106 4. The global harmonization initiative


3.14.7 Food safety limits 107
3.14.8 Process requirements 108 Huub Lelieveld and Veslemøy Andersen
3.14.9 Labeling 109 4.1 Introduction 139
3.14.10 Apps developed by FSSAI 111 4.2 Food and nutrient security 140
3.14.11 Human right to food and 4.3 International standards 140
food security 111 4.4 The global harmonization initiative 140
3.14.12 Specific issues 111 4.5 GHI association 141
Further reading 111 4.6 GHI ambassador programme 142
3.15 Pakistan 112 4.7 GHI working groups 142
3.15.1 Food safety standards and 4.7.1 Working group nomenclature
regulations 112 of food safety and quality 142
3.15.2 Status of food laws and 4.7.2 Working group chemical food
regulations 113 safety 143
3.15.3 Principles and concepts 113 4.7.3 Working group education and
3.15.4 Labeling 114 training of food handlers 143
3.15.5 Conclusion 115 4.7.4 Working group ethics in food
References 115 safety practices 143
Further reading 115 4.7.5 Working group food
3.16 Eastern Africa 115 microbiology 144
3.16.1 Introduction 115 4.7.6 Working group food packaging
3.16.2 Institutional 118 materials 144
3.16.3 Principles and concepts 118 4.7.7 Working group food
3.16.4 Standards 119 preservation technologies 144
3.16.5 Authorization requirements 120 4.7.8 Working group food safety in
3.16.6 Food safety limits 120 relation to religious dietary laws 145
3.16.7 Process requirements 121 4.7.9 Working group genetic
3.16.8 Labeling 121 toxicology and genomics 145
3.16.9 Human right to food/food 4.7.10 Working group global incident
security 122 alert network 146
3.16.10 Specific issues 122 4.7.11 Working group mycotoxins 146
References 122 4.7.12 Working group nanotechnology
Further reading 122 and food 146
3.17 Republic of South Africa 123 4.7.13 Working group nutrition 147
3.17.1 History and background 123 4.7.14 Working group reducing
3.17.2 Food regulatory system 124 postharvest losses 147
3.17.3 Major laws 126 4.7.15 Working group science
3.17.4 Additional aspects 128 communication 147
3.17.5 Labeling 131 4.7.16 Working group food law and
References 133 regulations 147
Further reading 133 4.8 GHI library 148
3.18 Private food law 134 4.9 Conclusion 148
3.18.1 Introduction 134 References 148
3.18.2 Triangular structure 134
3.18.3 Standards 134 5. Food safety regulations within
3.18.4 Standard setting countries of increasing global
organizations 134
supplier impact
3.18.5 Harmonization 134
3.18.6 Enforcement 135 Odel Yun LI and Xian-Ming Shi
3.18.7 Accreditation 135
5.1 Introduction 151
References 135
5.1.1 International food suppliers 151
Further reading 135
5.1.2 Global food supply chain 154
3.19 Conclusions 135
viii Contents

5.1.3 The impact of E-commerce 7.3 Why eating insects? 168


platform on global food supply 154 7.4 The consumers are having a say 168
5.2 Regulations of global food suppliers by 7.5 Regulatory aspects regarding insects for
international law and standards 154 human consumption 169
5.2.1 The recommendations of the 7.5.1 Codex Alimentarius 169
codex alimentarius commission 154 7.5.2 Regulating edible insects in the
5.2.2 Sanitary and phytosanitary European Union 169
standards of the World Trade 7.5.3 Regulating edible insects in the
Organization 155 USA 170
5.3 Regulations of global food suppliers by 7.5.4 Regulating edible insects in
domestic laws 155 Canada 170
5.3.1 USA 155 7.5.5 Regulating edible insects in
5.3.2 EU 155 Australia and New Zealand 171
5.4 Conclusion: supplier change and global 7.5.6 Regulating edible insects in
food safety regulation 156 Africa and Asia 171
Further reading 157 7.6 Conclusions 171
References 172
6. A simplified guide to understanding
and using food safety objectives and 8. Some thoughts on the potential of
performance objectives global harmonization of
L.G.M. Gorris, M.B. Cole and The International
antimicrobials regulation with a focus
Commission on Microbiological Specifications
on chemical foodsafety
for Foods Jaap C. Hanekamp
6.1 Introduction 159 8.1 Introduction 175
6.2 Good practices and hazard analysis 8.2 Global estimates of antimicrobials in
critical control point 160 food animalsdthe wrong and the right
6.3 Setting public health goalsdthe trousers 175
concept of appropriate level of 8.3 The “nature” of antimicrobials 176
protection 160 8.4 A precautionary tale and
6.4 Food safety objectives 161 chloramphenicol 177
6.5 Performance objectives 162 8.5 Risk profile of foods containing
6.6 The difference between food safety CAPdof exposure levels and
objectives, performance objectives, toxicological models 179
and microbiological criteria 162 8.6 Toward a straightforward
6.7 Responsibility for setting a food safety resolutiondIntended Normal Use 180
objective 163 References 183
6.8 Setting a performance objective 163
6.9 Responsibility for compliance with the 9. Substantiating regular, qualified, and
food safety objective 163 traditional health claims
6.10 Meeting the food safety objective 164
6.11 Not all food safety objectives are Bert Schwitters and Jaap C. Hanekamp
feasible 164 9.1 Introduction and background 187
6.12 Concluding remarks 164 9.2 When truth and certainty must
6.13 About the ICMSF 165 compete 188
Acknowledgments 165 9.3 Qualifying the certainty of
References 165 information 188
Further reading 166 9.4 RCT’s and plausibility 188
9.5 Traditional medicinal products in the
7. Regulating emerging food trends: EU 189
a case study in insects as food for 9.6 Health claims based on traditional use 190
humans 9.7 Basic evidential requirements 190
9.8 Qualifying the expert 191
Adina Alexandra Baicu
9.9 Reliability of the expert’s opinion 191
7.1 Introduction 167 9.10 Principles and methodology 192
7.2 Where and what? 167 9.11 Degree of scrutiny 192
Contents ix

9.12 Extrapolating results obtained in 12.2 Novel technologies 222


diseased subjects 192 12.3 Nonthermal technologies 223
9.13 Plausibility 193 12.4 Thermal technologies 224
9.14 The way forward 194 12.5 Legislative issues concerning novel
References 194 technologies 225
12.6 Global harmonization concerning
10. Benefits and risks of organic food novel technologies 225
12.7 Final remarks 227
H.K.S. De Zoysa and Viduranga Y. Waisundara
References 227
10.1 The modern food market 197
10.2 Why organic food? 197 13. Processing issues: acrylamide, furan,
10.2.1 Consumer attitude, and trans fatty acids
behavioral intentions, and
Lauren S. Jackson and Fadwa Al-Taher
preference toward organic
and nonorganic food 13.1 Introduction 229
products 198 13.2 Acrylamide 229
10.3 Organic food production and market 200 13.2.1 Introduction 229
10.3.1 Farming types 201 13.2.2 Occurrence and levels of
10.3.2 Retail marketing aspects of acrylamide in food 230
organic food 202 13.2.3 Mechanism of formation 233
10.4 Impact and benefits of organic food 203 13.2.4 Factors affecting formation 234
10.4.1 Nutritional composition 203 13.2.5 Prevention and mitigation 236
10.4.2 Health benefits 205 13.2.6 Health effects of dietary
10.4.3 Environmental concerns 206 acrylamide 239
10.4.4 Safety aspects 207 13.2.7 Regulatory status/risk
10.5 Limitations, gaps, and future management 240
research 208 13.3 Furan 241
10.6 Conclusions 210 13.3.1 Introduction 241
References 210 13.3.2 Occurrence and levels of
furan in food 241
11. Mycotoxin management: an 13.3.3 Mechanisms of formation 244
international challenge 13.3.4 Factors affecting furan
formation and mitigation
Rebeca López-Garcı´a
in food 245
11.1 Introduction 213 13.3.5 Health effects of dietary
11.2 Mycotoxin regulations 214 furan 246
11.3 Harmonized regulations 214 13.3.6 Regulatory status 246
11.3.1 Australia/New Zealand 215 13.4 Trans fatty acids 247
11.3.2 European Union 215 13.4.1 Introduction 247
11.3.3 MERCOSUR 215 13.4.2 Regulatory status/risk
11.3.4 ASEAN 215 management 247
11.3.5 Codex Alimentarius 216 13.4.3 Hydrogenation 248
11.4 Trade impact of regulations 217 13.4.4 Decreasing trans fatty acids
11.5 Technical assistance 218 in fats and oils 248
11.6 Conclusion 218 13.5 Conclusions 249
References 219 References 250

12. Novel food processing technologies 14. Food safety and regulatory survey
and regulatory hurdles of food additives and other
substances in human food
Gustavo V. Barbosa-Cánovas,
Daniela Bermúdez-Aguirre, Larry Keener
Beatriz Gonçalves Franco, Kezban Cando
gan
14.1 Introduction 259
and Ga Young Shin
14.1.1 Food additive 259
12.1 Introduction 221 14.1.2 Processing aids 262
x Contents

14.1.3 Cosmetic additivesd List of acronyms 311


comparison of EU and US Acknowledgment 314
color additive regulations 264 References 314
14.1.4 Prohibited and banned Websites of interest 323
substances 268
14.1.5 Conclusion 272 16. Nanotechnology and food safety
References 273
Syed S.H. Rizvi, Carmen I. Moraru,
Hans Bouwmeester, Frans W.H. Kampers and
15. Food contact materials legislation: Yifan Cheng
sanitary aspects
16.1 Introduction 325
Alejandro Ariosti 16.2 Nanotechnology and food systems 325
15.1 Introduction 275 16.2.1 Structure and function
15.1.1 Scope 275 characterization and
15.1.2 Foodepackaginge modification 326
environment interactions 275 16.2.2 Nutrient delivery systems 326
15.1.3 Importance of assessing and 16.2.3 Sensing and safety 327
controlling the interactions 279 16.2.4 Antimicrobials 327
15.1.4 Hygienic requirements of 16.2.5 Food packaging and tracking 328
FCMs 279 16.3 Current status of regulation of
15.2 FCMs legislation in the European nanomaterials in food 329
Union 285 16.3.1 North America 329
15.2.1 EU Framework Regulation 16.3.2 Europe 330
on FCMs 285 16.4 Hurdles in evaluation and regulation
15.2.2 EU regulation on GMP 286 of the use of nanotechnology in
15.2.3 EU legislation on specific foods 331
FCMs 286 16.4.1 Lack of a good definition 331
15.2.4 EU legislation on specific 16.4.2 Detection of manmade
substances 289 nanomaterials in complex
15.2.5 Legislation on kitchenware matrices, including foods 332
made of melamine or 16.4.3 Assessment of exposure to
polyamide originating nanoparticles 332
or consigned from China 16.4.4 Toxicity of nanoparticles 333
or Hong Kong 289 16.4.5 Characteristics and behavior
15.2.6 EC recommendation on the of nanoparticles in food 333
coordinated control plan of 16.5 Future developments and challenges 334
migrating substances from References 335
FCMs 289 Further reading 339
15.3 The Council of Europe technical
recommendations on FCMs 289 17. Monosodium glutamate in foods
15.4 FCMs legislation in the and its biological importance
United States 290
Helen Nonye Henry-Unaeze
15.5 FCMs legislation in the MERCOSUR 294
15.6 FCMs legislation in Japan 297 17.1 Introduction 341
15.7 FCMs legislation in China 299 17.2 Umami taste 343
15.7.1 GB standards of general 17.3 Glutamate in human metabolism 344
application (horizontal) 300 17.4 Nutritional studies 345
15.7.2 Commodity GB standards 303 17.5 Toxicological studies 346
15.7.3 GB 31603-2015 “general 17.6 Sensitivity 348
health code for production of 17.7 Health effects 348
FCMs and products” 304 17.8 Other effects 348
15.7.4 Compliance testing methods 304 17.9 Safety evaluations 349
15.8 Comparison of FCMs legislations 305 17.10 Labeling issues 349
15.9 Conclusionsdharmonization, mutual 17.11 Future perspective 349
recognition, and new legislations 306 References 349
Contents xi

18. Responding to incidents of low- 20.5.3 Australia and New Zealand 395
level chemical contamination and 20.5.4 Developing countriesd
deliberate contamination in food Codex Alimentarius 402
20.6 Nutrition labeling in different
Elizabeth A. Szabo, Elisabeth J. Arundell, countries 404
Hazel Farrell, Alison Imlay, Thea King, 20.7 Consumer understanding and use
Craig Shadbolt and Matthew D. Taylor of nutrition labels 405
18.1 Introduction 359 20.7.1 Front-of-pack nutrition
18.2 Risk analysis 360 labeling system 407
18.3 General control measures for 20.7.2 Global situation of FoPL 407
chemicals 362 20.7.3 Future directions of FoLP 408
18.3.1 Maximum residue limits for 20.8 Bioavailability and nutrition label 408
agricultural and veterinary 20.9 Conclusion 411
residues in food 362 20.10 Future scope 412
18.3.2 Maximum levels for Acknowledgments 412
contaminants in foods 363 References 412
18.4 Case study 1 364 Further reading 415
18.4.1 Naturally occurring
contamination: ciguatoxins 364 21. The first legislation for foods with
18.5 Case study 2 368 health claims in Korea
18.5.1 Deliberate tampering of Ji Yeon Kim, Sewon Jeong, Oran Kwon and
strawberries with needles 368 Sangsuk Oh
18.6 Case study 3 370
18.6.1 Environmental 21.1 Background 417
contaminationdper- and 21.2 Health/Functional Food Act 417
poly-fluoro alkyl substances 370 21.3 Health claims allowed for HFFs 418
18.7 Conclusion 374 21.4 Scientific substantiation of health
Acknowledgments 374 claims for HFFs 418
References 374 21.4.1 Identification and stability of
functional ingredients or
19. Nutraceuticals: possible future components 418
ingredients and food safety aspects 21.4.2 Safety evaluation of
functional ingredients or
M.A.J.S. van Boekel components 418
19.1 Introduction 379 21.4.3 Review of scientific
19.2 What are nutraceuticals? 379 substantiation of health
19.3 Supposed health effects 380 claims 419
19.4 Challenges 381 21.4.4 Re-evaluation 420
19.5 Regulations and safety issues 381 21.4.5 Kinds of functional
19.6 Conclusion 381 ingredients 420
References 382 21.4.6 Connection of scientific
evaluation to consumer
20. Nutrition and bioavailability: sense understanding 421
21.5 Future directions 421
and nonsense of nutrition labeling
References 422
Adelia C. Bovell-Benjamin
20.1 Introduction 383
22. Bioactivity, benefits, and safety of
20.2 Scope 385 traditional and ethnic foods
20.3 Methodology 386 Adelia C. Bovell-Benjamin
20.4 Structure of the review 386
20.5 Overview of nutrition labeling 386 22.1 Introduction 423
20.5.1 United States 386 22.2 Objective 424
20.5.2 Canada 388 22.3 Scope 424
xii Contents

22.4 Methodology 424 23.4.2 Water determination in


22.5 Structure of the review 424 a whey powder by NIR
22.6 Food and chronic diseases 424 spectroscopy 447
22.7 Biological mechanism of bioactive 23.4.3 Results and discussion of
food compounds 425 NIR measurements 448
22.8 Bioactive food compounds in 23.4.4 Concluding considerations 448
traditional/ethnic foods 427 23.5 Summary 450
22.8.1 Latin America 427 References 450
22.8.2 Africa 429
22.8.3 Asia 431 24. Global harmonization of analytical
22.9 Conclusion 434 methods
22.10 Future scope 434
Acknowledgments 435 Pamela L. Coleman, Anthony J. Fontana and
References 435 John Szpylka
Further reading 438 24.1 Introduction 453
24.2 Methods for establishing the basic
23. Water determination in food composition, quality, or economic
value of foods 454
Heinz-Dieter Isengard
24.3 Methods for establishing the nutrient
23.1 Introduction 439 content of foods 456
23.2 Water content 439 24.4 Methods for detecting or confirming
23.2.1 Importance of water content 439 the absence of contaminants in
23.2.2 Methods to determine water foods 458
content 440 24.5 Conclusion 459
23.2.3 Drying techniques 440 References 459
23.2.4 Karl Fischer titration 440
23.3 Water determination in dairy 25. Global harmonization of the control
powders 441 of microbiological risks
23.3.1 The lactose problemd
scientific background 441 Cynthia M. Stewart, Frank F. Busta and
23.3.2 The lactose problemd John Y.H. Tang
economic aspects 441 25.1 Introduction 461
23.3.3 Reference method for 25.2 Microbiological food safety
determining moisture in management 461
milk powders 441 25.3 Emerging foodborne pathogens 462
23.3.4 Mass loss, moisture content, 25.3.1 Salmonella spp. 463
and water contentd 25.3.2 Staphylococcus aureus 463
comparison of results 25.3.3 Campylobacter spp. 464
obtained by different 25.3.4 Escherichia coli 464
methods for various dairy 25.4 Microbiological criteria 465
powders 442 25.5 Microbiological testing 466
23.3.5 Oven drying 442 25.6 Validation of microbiological
23.3.6 Reference drying 442 methods 467
23.3.7 Karl Fischer titration 442 25.6.1 Association of analytical
23.3.8 General procedure 442 communities 468
23.3.9 Results and discussion 443 25.6.2 International organization
23.3.10 Concluding considerations 446 for standardization 468
23.4 Water content determination by 25.7 Harmonization of global regulations
near-infrared spectroscopy 447 for Listeria monocytogenes in
23.4.1 Rapid water determination ready-to-eat foods 469
by near-infrared 25.8 Conclusion 472
spectroscopy 447 References 472
Contents xiii

26. Testing for food safety using human 26.5.9 Application of human
competent liver cells (HepG2): HepG2 cell system to
a review detect dietary
antigenotoxicants 483
Firouz Darroudi 26.5.10 The use of genomic and
26.1 Introduction 475 proteomic technologies in
26.2 Assessment of human food safety HepG2 cells 483
and the current problems using 26.6 Conclusion 485
existing in vitro and in vivo assays 475 Acknowledgments 485
26.3 Human HepG2 cell system 476 References 485
26.4 Specific features of human HepG2
cells 476 27. Capacity building
26.5 Validation and application of human Larry Keener and Tatiana Koutchma
HepG2 cells and their S9-fractions in
genetic toxicology studies for 27.1 Introduction 489
assessing food safety 477 27.2 Capacity building 490
26.5.1 Assessment of the genotoxic 27.3 The role of multilateral agreements in
potential of known achieving food safety 492
carcinogen and 27.3.1 Historical developments in
noncarcinogens 477 food safety management and
26.5.2 Assessment of the genotoxic multilateral agreements 493
potential of mycotoxins 478 27.4 Unilateral food safety legislation for
26.5.3 Assessment of the genotoxic promoting capacity building 495
potential of heterocyclic 27.4.1 U.S. FDA Food Safety
aromatic amines 479 Modernization Act 496
26.5.4 Antigenotoxic potential of 27.4.2 European Union General
glycine betaine on a Food Law 498
heterocyclic aromatic 27.4.3 Safe Food for Canadians Act 499
amine Trp-p-2 in HepG2 27.5 Conclusion 500
cells 479 References 502
26.5.5 Toxicity studies of
compounds and 28. Capacity building: building
mechanistic assays on analytical capacity for microbial
NAD(P)H, ATP, DNA food safety
contents (cell proliferation),
Debdeep Dasgupta, Mandyam C. Varadaraj
glutathione depletion,
and Paula Bourke
calcein uptake, and radical
oxygen assay using human 28.1 Introduction 503
HepG2 cells 480 28.2 Significance of microbial food safety 503
26.5.6 The genotoxic potential of 28.3 Staphylococcus and its species 504
heavy metals in HepG2 28.3.1 Characteristics 504
cells 481 28.3.2 Methods of detection 505
26.5.7 To assess the genotoxic 28.4 Listeria monocytogenes 508
potential of human dietary 28.4.1 Conventional isolation
components in fermented methods 508
food and in alcoholic 28.4.2 Immunological detection
beverages using HepG2 methods 510
cells 481 28.4.3 Nucleic acidebased methods 510
26.5.8 To assess DNA damage 28.4.4 Other methods 512
induction, repair kinetics, 28.5 Bacillus cereus 512
and biological 28.5.1 Detection methods 513
consequences of chemical 28.6 Capacity building in India 515
mutagens/carcinogens in References 517
HepG2 cells 482 Further reading 523
xiv Contents

29. Role of education and training of leading causes of illness


food handlers in improving food among young and old alike,
safety and nutrition: the Indian especially in developing
experience countries 526
References 531
Jamuna Prakash
29.1 Food environment: dietary and
nutrition transition as prime Index 533
determinants of food behavior 525
29.1.1 Food and waterborne
infections are one of the
List of contributors

Fadwa Al-Taher, VDF FutureCeuticals, Inc., Momence, Yifan Cheng, Department of Food Science, Cornell Uni-
IL, United States versity, Ithaca, NY, United States
Veslemøy Andersen, Global Harmonization Initiative M.B. Cole, Head, School of Agriculture Food and Wine.
(GHI), Vienna, Austria University of Adelaide, Urrbrae, SA, Australia
Alejandro Ariosti, National Institute of Industrial Tech- Pamela L. Coleman, Mérieux NutriSciences, Chicago, IL,
nology (INTI) e Plastics Center, Buenos Aires, United States
Argentina; Department of Food Science, Faculty of Firouz Darroudi, Global Harminization Initiaitve (GHI),
Pharmacy and Biochemistry, University of Buenos Section of Genetic Toxicology and Genomics, Oegst-
Aires (UBA), Buenos Aires, Argentina geest, The Netherlands
Elisabeth J. Arundell, The New South Wales Department Debdeep Dasgupta, Department of Microbiology, Sure-
of Primary Industries, Orange, NSW, Australia ndranath College-Kolkata, Kolkata, West Bengal, India
Adina Alexandra Baicu, University of Agronomic Sci- H.K.S. De Zoysa, Department of Bioprocess Technology,
ences and Veterinary Medicine of Bucharest, Romania Faculty of Technology, Rajarata University of Sri
Gustavo V. Barbosa-Cánovas, Center for Nonthermal Lanka, Anuradhapura, North Central Province, Sri
Processing of Food, Washington State University, Lanka; Department of Biology, University of Naples
Pullman, WA, United States Federico II, Naples, Italy
Daniela Bermúdez-Aguirre, Center for Nonthermal Pro- Ahmad Din, National Institute of Food Science & Tech-
cessing of Food, Washington State University, Pullman, nology, University of Agriculture, Faisalabad, Pakistan
WA, United States Hazel Farrell, The New South Wales Department of Pri-
_
Fehmi Kerem Bilgin, Izmir Bakirçay University, Faculty mary Industries, Taree, NSW, Australia
_
of Law, Menemen, Izmir, Turkey Anthony J. Fontana, Mérieux NutriSciences, Chicago, IL,
Paula Bourke, School of Biosystems and Food Engi- United States
neering, University College Dublin, Dublin, Ireland Neal D. Fortin, Institute for Food Laws and Regulations,
Hans Bouwmeester, Division of Toxicology, Wageningen Michigan State University, East Lansing, MI, United
University and Research, Wageningen, the Netherlands States
Adelia C. Bovell-Benjamin, Food and Nutritional Sci- Beatriz Gonçalves Franco, Center for Nonthermal Pro-
ences, Tuskegee University, Tuskegee, AL, United cessing of Food, Washington State University, Pullman,
States WA, United States
Julie Larson Bricher, Quiddity Communications, Inc., L.G.M. Gorris, Food Safety Expert, Food Safety Futures,
McMinnville, OR, United States Nijmegen, The Netherlands
Frank F. Busta, University of Minnesota, Minneapolis, St. Jaap C. Hanekamp, University College Roosevelt, Mid-
Paul, MN, United States delburg, the Netherlands; Environmental Health Sci-
gan, Faculty of Engineering, Department
Kezban Cando ences, University of Massachusetts Amherst, Amherst,
of Food Engineering, Ankara University, Ankara, MA, United States; HAN-Research, Zoetermeer, the
Turkey Netherlands

Melissa M. Card, Institute for Food Laws & Regulations, HelenNonyeHenry-Unaeze, Department of Food, Nutrition
MSU, Michigan State University’s College of Law, and Home Science, Faculty of Agriculture, University of
United States Port Harcourt, East-West Road Choba, Rivers, Nigeria

xv
xvi List of contributors

Alison Imlay, The New South Wales Department of Pri- V.D. Sattigeri, Food Safety and Analytical Quality Control
mary Industries, Silverwater, NSW, Australia Laboratory, Central Food Technological Research
Heinz-Dieter Isengard, University of Hohenheim, Institute Institute, Mysuru, Karnataka, India
of Food Science and Biotechnology, Stuttgart, Germany Bert Schwitters, Independent Researcher
Lauren S. Jackson, U.S. Food and Drug Administration, Craig Shadbolt, The New South Wales Department of
Division of Food Processing Science & Technology, Primary Industries, Silverwater, NSW, Australia
Bedford Park, IL, United States Xian-Ming Shi, MOST-USDA Joint Research Center for
Sewon Jeong, BiofoodCRO, Seoul, Korea Food Safety, School of Agriculture and Biology, State
Katy A. Jones, FoodLogiQ, Durham, NC, United States Key Lab of Microbial Metabolism, Shanghai Jiao Tong
University, Shanghai, China
Frans W.H. Kampers, Wageningen UR, Wageningen, the
Netherlands Ga Young Shin, Center for Nonthermal Processing of
Food, Washington State University, Pullman, WA,
Larry Keener, International Product Safety Consultants, United States
Seattle, WA, United States
Mungi Sohn, Food Science and Biotechnology, College of
Ji Yeon Kim, Department of Food Science and Technol- Life Sciences, Kyung Hee University, Republic of
ogy, Seoul National University of Science and Tech- Korea
nology, Seoul, Korea
Cynthia M. Stewart, Silliker Food Science Center, South
Thea King, The New South Wales Department of Primary Holland, IL, United States
Industries, Silverwater, NSW, Australia
Juanjuan Sun, Food Law, Nantes University of France,
Tatiana Koutchma, Agriculture and Agri Foods, Canada Center for Coordination and Innovation of Food Safety
Oran Kwon, Department of Nutritional Science and Food Governance, Renmin University, Beijing, China
Management, Graduate Program in System Health Elizabeth A. Szabo, The New South Wales Department of
Science and Engineering, Ewha Womans University, Primary Industries, Silverwater, NSW, Australia
Seoul, Korea
John Szpylka, Mérieux NutriSciences, Chicago, IL,
Joe Lederman, FoodLegal, Australia United States
Huub Lelieveld, Global Harmonization Initiative (GHI), John Y.H. Tang, Universiti Sultan Zainal Abidin, Ter-
Vienna, Austria engganu, Malaysia
Rebeca López-García, Logre International Food Science Matthew D. Taylor, The New South Wales Department of
Consulting, Mexico Primary Industries, Taylors Beach, NSW, Australia
Alida Mahmudova, Bona Mente Consulting LLC Law The International Commission on Microbiological
Company, Azerbaijan Specifications for Foods, www.icmsf.org
Bernard Maister, Intellectual Property Unit, University of _
Halide Gökçe Türkoglu, Izmir Bakirçay University, Fac-
Cape Town, Cape Town, South Africa _
ulty of Law, Menemen, Izmir, Turkey
Carmen I. Moraru, Department of Food Science, Cornell Altinay Urazbaeva, Studying Advanced Master Program in
University, Ithaca, NY, United States European, International Business Law, Leiden University
Sangsuk Oh, Department of Food Science and Technol- M.A.J.S. van Boekel, Food Quality & Design Group,
ogy, Ewha Womans University, Seoul, Korea Wageningen University & Research, Wageningen, the
Margherita Paola Poto, K. G. Jebsen Centre for the Law Netherlands
of the Sea, UiT, Tromsø, Norway Bernd van der Meulen, GHI, Prof. Comparative Food
Jamuna Prakash, Global Harmonization Initiative, Austria Law, Renmin University of China School of Law,
Syed S.H. Rizvi, Department of Food Science, Cornell University of Copenhagen, European Institute for Food
University, Ithaca, NY, United States Law, Amsterdam, The Netherlands
List of contributors xvii

Mandyam C. Varadaraj, Department of Human Resource Viduranga Y. Waisundara, Australian College of Busi-
Development, Central Food Technological Research ness & Technology - Kandy Campus, Peradeniya Road,
Institute, Mysore, Karnataka, India Kandy, Central Province, Sri Lanka
Yuriy Vasiliev, Stavropol Branch, North Caucasus Civil Odel Yun LI, Shanghai Jiao Tong University, Shanghai
Service Academy, Russia Legislative Research Institute, Shanghai, China
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Chapter 1

Introduction: Ensuring global food safety:


A public health priority and a global
responsibility
Julie Larson Bricher
Quiddity Communications, Inc., McMinnville, OR, United States

Only if we act together can we respond effectively to international food safety problems and ensure safer food for everyone.
Dr. Margaret Chan, former Director-General, World Health Organization.

Dr. Margaret Chan’s words served as the opening quote of this book during its first publication nearly a decade ago. We
have seen improvements in global health outcomes in the past 10 years, in part due to political and community pressure to
implement evidence-based and scientifically informed health and food safety policies and legislation on a global scale.
Chan’s words ring especially true today: It was only through community effort that these improved outcomes were
achieveddand it is only through continued community effort that we can ensure that safe food in adequate supply is the
reality for all the world’s people.
The march toward globalization appears inexorable, even as the trend remains politically controversial on the world
stage. The International Monetary Fund defines globalization as “the process through which an increasingly free flow of
ideas, people, goods, services, and capital leads to the integration of economies and societies” (IMF, 2006). At its core,
globalization is a process driven by free trade economics and an ideal driven by the promise of greater societal benefits for
all peoples of the world.
Proponents put forward that an economy without borders spurs greater market competition and therefore economic
freedom, driving down prices and increasing availability and variety of affordable goods and services for a greater number
of people. In turn, globalization promises further benefits, such as increases in productivity, access to new technologies and
information streams, and higher living, environmental, and labor standards for those in both developed and developing
countries. Critics charge that inherent economic and infrastructure inequalities that exist between developed and devel-
oping nations preclude less developed and poorer nations from fully realizing these benefits.
Whatever the measurable positive benefits experienced by some countries in recent years, there remain tangible
challenges not only brought on by the rapid acceleration of globalization in the world economy but the impact of global
climate change on the planet’s food supply. Perhaps there are no statistics more compelling than those of the 2018 World
Resources Institute’s report, “Creating a Sustainable Food Future,” which projects that the human population is expected to
grow from 7 billion in 2010 to 9.8 billion in 2050. The demand for food is estimated to increase by more than 50% and
demand for animal-based foods by nearly 70% (WRI, 2018). According to the report, major changes to the global food
systemdby farmers, food companies, consumers, and governmentsdwill be necessary to mitigate looming food shortages
worldwide.
In addition, nearly 2 decades into the 21st century, the challenges of ensuring food security, food safety, and nutrition
on a global scale continue to grow in complexity. Recent statistics show that the levels of world hunger, malnutrition, and
food- and waterborne diseases are among the most critical global public health issues facing the international community.
For example:
l According to the Food and Agriculture Organization (FAO) of the United Nations, 10.9% of the world’s population are
undernourished, down from 14.5% in 2005. This percentage still represents roughly 770 million people (FAO, 2018).

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2 Ensuring Global Food Safety

l Globally, 22.7% of children under five who experience undernourishment suffer from stunted growth (FAO, 2018).
l The World Health Organization (WHO) reports that more than 1000 children under five die daily from diarrheal disease
caused by inadequate access to water sanitation (WHO, 2014).
l In 2015, foodborne diarrheal disease agents alone were the cause of death for more than 230,000 people (WHO, 2018;
WHO 2015).
l Worldwide, nearly 1 in 10 people fall ill from all foodborne diseases, which equates to 33 million healthy life years lost
and results in the deaths of approximately 420,000 people (WHO, 2015). Children account for one-third of deaths from
foodborne diseases.
l In developed countries, one in three consumers get a foodborne disease associated with microbes or their toxins every
year. This does not include other foodborne diseases associated with naturally occurring or man-made chemical con-
taminants, such as aflatoxin, acrylamide, furan, or dioxin (Schlundt, 2008).
The WHO Initiative to Estimate the Global Burden of Foodborne Diseases identifies the rapid globalization of food
trade as a worldwide trend that has introduced an increased potential for contaminated food to adversely affect greater
numbers of people (WHO, 2015). As the food supply chain becomes more integrated, the potential for massive foodborne
illness outbreaks caused by pathogens, chemicals, viruses, and parasites increasesdas do the difficulties in controlling
foodborne infections, morbidity, disability, and mortality.
Rapid globalization also has exposed critical gaps in national and international capabilities to assure adequate levels of
food safety and quality. Disparities related to national infrastructural and technological capacities and international food
production, distribution and handling standards, and law have become more visible as global commerce becomes more
interconnected. As a result, WHO and other food-related international public health, development, and standard-setting
bodies have targeted these gaps as priority items and are working together to reinforce the need to use an integrated in-
ternational food safety regulatory system in the era of “one global market.”
To be effective, such a system must include advancing the use of risk analysis and management to better direct re-
sources toward areas of high risk, providing a scientific basis for international food safety action, moving from conven-
tional “vertical” legislation within nations to more “horizontal” rulings among nations to attain harmonization of standards
and reduce barriers to trade, and building capacity to promote the availability and use of new food safety technologies,
testing and preventing strategies that will reduce the public health risks of foodborne disease around the globe.
In the second edition of this volume, Ensuring Global Food SafetydA Public Health Priority and a Global Re-
sponsibility, members of the Global Harmonization Initiative (GHI) once again contribute to the world dialogue, discussing
tools for promoting harmonization of scientific methods, standards, and regulations. Established in 2004, GHI is a network
of international scientific organizations and individual scientists that aims to achieve objective consensus on the science of
food regulations and legislation to ensure the global availability of safe and wholesome food products for all consumers.
With support and participation of its individual members and member organizations, the GHI’s Working Groups have
conducted a series of meetings at which members have formulated approaches to critically (re-)evaluate the scientific
evidence used to underpin existing global regulations in the areas of product composition, processing operations, and
technologies or measures designed to prevent foodborne illness. Each chapter is reflective of outcomes of these discussions
and progress in developing strategies to find the shortest route to achieving global harmonization in concert with inter-
national public health and food safety authorities, including the WHO, FAO, the Codex Alimentarius Commission (CAC),
and the International Organization for Standardization (ISO).
GHI’s overarching objective is to provide regulators, policymakers, and public health authorities with a foundation for
sound, sensible, science-based international regulations in order to eliminate hurdles to scientific advancement in food
safety technology. For example, there is no question that the more that the avenues of global trade narrow, the higher the
probability of traffic jams in worldwide commerce. Barriers to trade in the form of differingdand sometimes
conflictingdcountry-by-country import/export rules and requirements can and do make it difficult for food businesses to
get traction in overseas markets.
Food safety concerns are frequently cited by individual nations as underpinning the justification for their legislative acts
and rulemakingdand for erecting trade barriers and other measures that have the impact of curtailing free trade. Unfor-
tunately, in some cases, the science used to inform and bolster food safety policymaking is insufficient, inconsistent, or
contradictory, creating a roadblock to the promulgation of laws that have a clear and evident benefit to protecting public
health.
Introduction: Ensuring global food safety: A public health priority and a global responsibility Chapter | 1 3

National differences in food safety regulations and laws also trigger a red light to the advances offered by science and
technology. Though many food companies throughout the world have invested significant monies to food safety and
nutrition technology research and development efforts, industry is understandably hesitant to apply newly developed
capabilities on an international scale in an uncertain, maze-like regulatory environment.
GHI anticipates that elimination of regulatory differences will make it more attractive for the private sector to invest in
food safety and nutrition research and development, consequently strengthening the competitiveness of each nation’s food
industry and of the industries supplying the food sector. Harmonizing global regulations will aid in the uptake and
application of new technologies and encourage the food industry to invest in technologies to ensure the safety, quality, and
security of the global food supply.
Ultimately, “globalizing” food safety regulations and laws based on sound science can only serve to help bridge public
health gaps and create opportunities for all stakeholders to realize the big picture benefits promised by economic glob-
alization, including measurable global reductions in morbidity and mortality associated with foodborne disease; increases
in food availability to combat malnutrition and enhance food security for consumers worldwide; and decreases in poverty
rates among less-developed or impoverished nations through capacity building that enables full participation in the
global economy.
For public health agencies responsible for overseeing the safety of the international food supply, harmonization of
food safety and quality standards and regulations will bring a higher level of confidence that risk reduction strategies and
food safety measures are effective and that decisions taken are based on science and not on underlying political agendas
that may be in conflict with public health goals. Harmonization will also ensure that available resources are allocated
where they have the highest impact on the most pressing food diseaseerelated problems.
To paraphrase WHO Director General Chan, it is only through collective action that we can fully embrace our global
responsibility to respond effectively to the challenges of ensuring food security, food safety, and nutrition for everyone. As
the authors in this volume attest, meeting that global responsibility requires cooperation, collaboration, and consensus
building if we are to achieve harmonization of food regulations and standards, and thereby accomplish even greater gains
in global public health.

References
Food and Agriculture Organization, 2018. World Food and Agriculture - Statistical Pocketbook 2018. http://www.fao.org/publications/card/en/c/
CA1796EN.
International Monetary Fund, 2006. Glossary of Selected Financial Terms. http://www.imf.org/external/np/exr/glossary/showTerm.asp#91.
Schlundt, J., 2008. Food safety: a joint responsibility. In: 14th World Congress of Food Science and Technology. Shanghai, China. October 20, 2008.
World Health Organization, 2014. Preventing Diarrhoea through Better Water, Sanitation and Hygiene. https://www.who.int/water_sanitation_health/
publications/gbd_poor_water/en.
World Health Organization, 2015. WHO Estimates of the Global Burden of Foodborne Diseases: Foodborne Disease Burden Epidemiology Reference
Group, 2007e2015. http://www.who.int/iris/handle/10665/199350.
World Resources Institute, 2018. Synthesis Report: Creating a Sustainable Future: A Menu of Solutions to Feed Nearly 10 Billion People by 2050. Full
report to be published in 2019. www.wri.org/publication/creating-sustainable-food-future.
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Chapter 2

Safety and security: the costs and


benefits of traceability and transparency
in the food chain
Katy A. Jones
FoodLogiQ, Durham, NC, United States

The food supply chain is one of the most important business aspects of food companies and restaurants. It is critical to
every operation and provides organizations with the opportunity to build and deliver their brand promise. An efficient,
well-managed food supply chain can help to improve operational efficiency, mitigate risk, improve brand reputation, and
increase (or maintain) consumer confidence in the products being served to customers.
But these benefits are only achievable if supply chains are kept safe and secure. This requires supply chains that are
monitored and tracked using strong processes supported with advanced technologies. As a food company or restaurant, it is
critical to track and monitor the supply chain to reduce the overall risk to the branddand to the customers. In this chapter,
we will look into the costs of foodborne outbreaks not only to society but to the impact of the business as well.

2.1 The burden of foodborne outbreaks


2.1.1 Each year 48 million people get sick from foodborne illnesses, 128,000 are hospitalized, and
3000 die (Centers for Disease Control and Prevention, 2015)
Many people are under the assumption that foodborne illness is more of a problem in developing countries where reg-
ulations are not as strict, but it hits closer to home more often than we think. The Centers for Disease Control and Pre-
vention (CDC) in the United States of America closely monitor all cases of foodborne illness that come through the United
States, and the statistics are not pretty.
It’s nearly impossible to eradicate foodborne illnesses. There are too many factors that go into it, some out of our
control, but more can be done for prevention. When organizations employ enhanced traceability programs, combined with
effective safety plans, auditing and corrective actions, the risks of contamination can be much lower. Depending on where
you are, companies should be able to monitor exactly where their food was, is, and will be, maintaining total visibility
across the supply chaindand react quickly when a food safety issue hits.
Additionally, when foodborne illnesses occur, traceability can reduce exposure. As soon as the adulterated food is
identified and the root cause is identified, it can be recalled to prevent further illness and used to analyze the medical action
needed to rectify the situation.

2.1.2 About 23% of U.S. food recalls cost the food industry over $30 million and 14% cost
organizations over $50 million (Grocery Manufacturers Association, 2011)
These statistics are staggering. Executing a recall on food products can be a manufacturer’s worst nightmare simply
because of the time and money lost. Recalling products is an essential part of maintaining public health, but it can be
stressful.

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6 Ensuring Global Food Safety

Consider one E. coli outbreak in Germany (Centers for Disease Control and Prevention, 2014). It’s difficult to contain,
and in this instance, there was not strong traceability throughout the supply chain. 3800 people were affected worldwide,
47 died, and European Union farmers lost V417 million ($611 million) (Grieshaber, 2011). The holistic cost of this
incident shows that traceability is essential to healthy food industries.
And according to a study from researchers at John Hopkins Bloomberg School of Public Health, a single foodborne
disease outbreak at a fast-casual establishment could cost between $6330 and $2.1 million in lost revenue, fines, and
lawsuits. And this is only on the financial side.

2.1.3 Reducing foodborne illnesses by just 1% would prevent nearly 500,000 Americans from
getting sick each year
If we were able to reduce foodborne illness by 1%, nearly 500,000 Americans could avoid sickness. This will require a
more strategic approach from individuals and food organizations alike.
Reducing foodborne illnesses so drastically will require a new perspective on how we view foodborne illnesses and
mitigate risks. In 2013, the United States spent about $40 million on treating the problem but not preventing it. Through the
adoption of traceability supported by technology, organizations can shift the focus toward prevention, saving money, and
lives.
Reducing foodborne illnesses will not be an easy task, and it relies on individual organizations making decisions that
impact society as a whole. As they employ traceability, they will start to make an impact and take us closer to reducing
these issues.

2.2 The food supply chain: increasing risk


Food supply chains are growing increasingly complex, global, and fresh. Consumers are driving for more fresh format
concepts and want healthier options overall. Yet that profile of supply chain in theory has increased risk.
Fresh produce items like cilantro, cucumbers, cantaloupes, and peppers that are often eaten raw cause more foodborne
illness than any other single category of food, according to a study by the Center for Science in the Public Interest (CSPI)
(Food Safety News, 2015). The nonprofit food safety group reviewed 10 years of outbreak data to determine which foods
are most often linked to outbreaks of foodborne disease and identify trends in illnesses. Over the period studied, fresh
produce caused 629 outbreaks and almost 20,000 illnesses.
But that does not mean Americans should avoid fruits and vegetables, CSPI says. While the number of outbreaks and
illnesses is large, on a pound-for-pound basis fresh produce is safer than many other foods.
Over the period studied, there was a total of 193,754 illnesses reported from 9626 outbreaks. Of the total number of
reported outbreaks, the CDC was able to identify both the food source and the contaminant in fewer than 40%. CSPI only
reviewed the 3485 solved outbreaks.
The report also found that seafood caused more illnesses per pound consumed than any other food category, while
fruits, vegetables, and dairy caused the fewest illnesses per pound consumed.

2.3 Working toward traceability and transparency


Now that we have established the burden of the issue and the associated risk in the food supply chain, we ask ourselves
what are the real costs associated with a failure in transparency and traceability?
Food regulatory requirements have shifted in nature; now, rather than primarily focusing on responding to food safety
incidents, there is an increased emphasis on food safety prevention. Fortunately, there are a variety of tools to help food
and beverage manufacturers ensure that they are compliant with food safety regulations; the key is preparing for food
safety audits in advance. Audits can occur in-house by a dedicated team or by an external auditor, with the purpose being to
identify areas for improvement to processes and systems.
Under U.S. Food and Drug Administration (FDA) guidelines and regulations under the Food Safety Modernization Act,
food and beverage manufacturers must have a food safety plan in place that includes oversight and management of
preventive controls established in each manufacturing facility. Regulatory audits and audit reports must be submitted to the
FDA. In 2019, the FDA announced the New Era of Smarter Food Safety initiative that encompasses four pillars that
include tech-enabled traceability, smarter tools for prevention, adapting to new business models in retail, and food safety
culture. The blueprint released also includes proposed Section FSMA 204 rulemaking to harmonize the key data elements
and critical tracking events needed for enhanced traceability (FDA New Era of Smarter Food Safety).
Safety and security: the costs and benefits of traceability and transparency in the food chain Chapter | 2 7

In Europe, the European Food Safety Authority (EFSA), established in 2002, oversees the regulation of the food supply
chain. The organization’s mission is “to deliver independent, high-quality and timely scientific advice on risks in the food
chain from farm to fork in an integrated manner and to communicate on those risks in an open manner to all interested
parties and the public at large.”
The exact same law that established EFSA, Regulation EC/178/2002, also established the basis for food traceability in
Europe. Under the law, any food produced in Europe or imported into Europe is subject to an incredibly high standard for
traceability. The regulation requires that both food manufacturers and distributors demonstrate “the ability to trace and follow
food, feed, and ingredients through all stages of production, processing, and distribution“ (European Commission, 2019).
Although going through an audit can be a stressful event, a passing result will assure you and your team that your
company has achieved a satisfactory level of food safety. A successful audit also lets consumers know that your company
prioritizes their wellbeing.

2.4 The costs associated to a lack of traceability


With a managed, improved, and efficient food supply chain in place, businesses can begin to reap other benefits. This can
include financial gains, such as an increase in credit request approvals and a reduction in insurance premium costs.

2.4.1 Issues with labeling and brand claims


Providing proof of your product claims is by itself enough to boost your business’ reputation in the industry and
worldwide. With access to robust supply chain data, companies can proactively remove any issues that may negatively
impact your brand in the future. By identifying quality issues in advance, you can protect your brand commitment and your
business’ reputation.
For example, you can communicate across your supply chain to prevent poor or tainted products from being delivered
to your consumer. To examine the real potential return on investment that supply chain transparency can achieve, let us
look at an example:
A consumer packaged goods company that produces nut-free granola bars has been notified that a lot from its oat
supplier actually contained traces of walnut, when the allergen claim on the packaging does not list tree nuts. The issues
have only been identified after the batch has been sent out to retailers and put on shelves. The batch of 1500 cases had an
average sale price of $40, totaling $60,000 worth of sales. $20,000 of that sales figure was sunk manufacturing costs (the
cost of the raw ingredients, manufacturing, and labor).
Without Supply Chain Traceability: The manufacturer is slow to respond to the crisis.
It takes time for staff to identify if the contaminated batch has been sent to figure out exactly which stores were sent the
tainted product. This equates to a labor cost of $1,000. Once the shipment locations have been identified, the manu-
facturer has the opportunity to get the sales back quickly if they can replace the product. There is a 6% logistics
cost of $3,000 to recall the products and a $9,000 cost to expedite delivery of the new product. All of this is on top
of the $20,000 cost of manufacturing the new product. This is a total cost of $33,000. However, because the product
defect was not caught before it went on sale, the manufacturer’s reputation is severely damaged. Consumers no longer
trust their product, and they see a 20% drop in sales. The company’s share price also falls as a result.
With Supply Chain Traceability: With enhanced traceability in place, the situation is a different story. Corporate food
safety can use data to instantly see that the contaminated batch has only been sent to three store locations. The $1,000
labor cost is significantly reduced.
Companies that utilize traceability can also benefit from an average 30% reduction in the direct costs associated with a
recall. So instead of the logistical costs totaling $12,000, the costs only total $8000. That is a saving of $4000.
Because the company is able to quickly respond to the issue and pull the tainted product from the exact store locations,
the damage to their brand is greatly reduced. They may see a small reduction in sales but not near the damage caused
from a long, drawn-out recall played out in the news media and social media.

2.4.2 Restrictions to market access


With globalization comes the opportunity for businesses to enter new markets across the world with relative ease. A
traceable supply chain can help to ease compliance regulation on a global scale. With a traceable supply chain, you can
ensure that all trading partners meet or exceed the minimum acceptable standards for markets across the globe.
8 Ensuring Global Food Safety

Enhanced traceability connects every stage of the supply chain; the manufacturer was able to identify where the nuts
entered the manufacturing process. The issue was the fault of a well-known supplier, not the manufacturer and it is the
supplier that suffers the reputational damage. The manufacturer still sees a slight decrease in sales, but it is able to save its
reputation and its share price.

2.5 Benefits beyond food safety


We all know the important role food supply chain traceability plays in food safety. Being transparent about where your
food comes from helps put customers’ minds at easedand also can help resolve a food safety issue more quickly, should
one arise. But what about the other benefits food supply chain traceability? Can being transparent about your supply chain
provide an additional return of investments for your business, beyond safety?
Today’s consumers are more concerned than ever about what they are eating and where their food is coming from. With
this trend toward awareness and transparency, businesses can capitalize on additional benefits, simply by telling your
customers more about your processes. Here is how:

2.5.1 Enhanced credibility


Being open about your supply chain shows you have nothing to hide. This transparency will resonate with customers and
help build the credibility of your business as a trusted place to bring their business. Improving your credibility can also help
to further establish your branding and help you stand out from the competition. Your customers will be more likely to
choose you knowing they can trust where your food comes from.

2.5.2 Transparent marketing


Supply chain traceability allows you to create a “farm-to-fork” story that can be a very effective marketing tool. Consumers
like to know they are putting good, clean ingredients in their body and they like to know they are supporting local farmers
at the same time. By using your supply chain as a marketing tool, you can attract a health-conscious audience. While many
companies like to claim their food is “farm fresh,” traceability allows you to authenticate your sources.

2.5.3 Increased reliability for consumers


Meticulously tracing your supply chain helps to ensure consistent quality of suppliers across each chain or franchise of
your business. This means the food your customers eat is always exactly the same, regardless of which location they visit.
This level of reliability and consistency helps solidify your brand and lets your customers know they can trust your
product. Rather than worrying your food may be “hit or miss” depending on location, they will know what level of quality
they can expect.

2.6 More operational efficiency


You depend on your supply chain to maintain efficiency in the daily operations of your business. Traceability helps to
improve communication between you and your suppliers, which keeps everyone on the same page and helps improve
efficiency. When your processes are running smoothly, your relationships with your suppliers, employers, and customers
all benefit.
The benefits of food supply traceability go well beyond food safety. With the opportunity to improve your business’
branding, marketing, reputation, and processes, traceability is an investment that can transform your entire business.

References
Centers for Disease Control and Prevention, 2014. Questions about the 2011 E. coli Outbreak in Germany (accessed 19.10.10.). www.cdc.gov/ecoli/
germany.html.
Centers for Disease Control and Prevention, 2015. Surveillance for Foodborne Disease Outbreaks United States, 2013: Annual Report.
European Commission, 2019. Food Law General Requirements (accessed 19.10.16.). https://ec.europa.eu/food/safety/general_food_law/general_
requirements_en>.
Safety and security: the costs and benefits of traceability and transparency in the food chain Chapter | 2 9

Food Safety News, 2015. Fresh Produce Responsible for Most Foodborne Illnesses in the U.S (accessed 19.10.10.). www.foodsafetynews.com/2015/12/
report-fresh-produce-responsible-for-most-foodborne-illness-outbreaks/.
Grieshaber, K., 2011. 2 New E. coli Deaths as EU Holds Emergency Meeting. The Post and Courier.
Grocery Manufacturers Association, 2011. Capturing Recall Costs: Measuring and Recovering the Losses.
FDA New Era of Smarter Food Safety, 2021. (Accessed 26 October 2021).
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Chapter 3

Food regulation around the world


Bernd van der Meulen1, Melissa M. Card2, Ahmad Din3, Neal D. Fortin4, Alida Mahmudova5,
Bernard Maister6, Halide Gökçe Türko
glu7, Fehmi Kerem Bilgin7, Joe Lederman8, Margherita Paola Poto9,
V.D. Sattigeri , Mungi Sohn , Juanjuan Sun12, Altinay Urazbaeva13 and Yuriy Vasiliev14
10 11
1
GHI, Prof. Comparative Food Law, Renmin University of China School of Law, University of Copenhagen, European Institute for Food Law,
Amsterdam, The Netherlands; 2Institute for Food Laws & Regulations, MSU, Michigan State University’s College of Law, United States; 3National
Institute of Food Science & Technology, University of Agriculture, Faisalabad, Pakistan; 4Institute for Food Laws and Regulations, Michigan State
University, East Lansing, MI, United States; 5Bona Mente Consulting LLC Law Company, Azerbaijan; 6Intellectual Property Unit, University of
_
Cape Town, Cape Town, South Africa; 7Izmir _
Bakirçay University, Faculty of Law, Menemen, Izmir, Turkey; 8FoodLegal, Australia; 9K. G. Jebsen
10
Centre for the Law of the Sea, UiT, Tromsø, Norway; Food Safety and Analytical Quality Control Laboratory, Central Food Technological
11
Research Institute, Mysuru, Karnataka, India; Food Science and Biotechnology, College of Life Sciences, Kyung Hee University, Republic of
12
Korea; Food Law, Nantes University of France, Center for Coordination and Innovation of Food Safety Governance, Renmin University, Beijing,
13 14
China; Studying Advanced Master Program in European, International Business Law, Leiden University; Stavropol Branch, North Caucasus
Civil Service Academy, Russia

Chapter 3.1

Introduction
Bernd van der Meulen
GHI, Prof. Comparative Food Law, Renmin University of China School of Law, University of Copenhagen, European Institute for Food Law,
Amsterdam, The Netherlands

3.1.1 Purpose of this chapter


Against the background of global harmonization through scientific consensus, this chapter provides an inventory of
approaches to the regulation of food and related issues in a variety of jurisdictions around the world. To each jurisdiction, a
separate section is dedicated. Each section has been written by an author well versed in the jurisdiction at issue.
The sections can be read as independent texts.

3.1.2 Food law


We have labeled the rules and regulations that apply to the food sector “food law.” This label can cover two closely related
but distinguishable phenomena. It may relate to a branch of law recognized within a legal system that is labeled “food law”
or the outcome of an analysis of the legal system from the perspective of the food sector. If the latter, one can speak of a
functional feed of law.1 In this chapter, we approach the topic from this functional perspective.

1. On this concept, see: Bernd van der Meulen, The Functional Field of Food Law. The Emergence of a Functional Discipline in the Legal Sciences,
European Institute for Food Law working paper 2018/02. Available at < http://www.food-law.nl/Working-papers/>.

Ensuring Global Food Safety. https://doi.org/10.1016/B978-0-12-816011-4.00001-X


Copyright © 2022 Elsevier Inc. All rights reserved. 11
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The trunks which were shipped from Tobolsk reached the house but
they were taken directly to the attic. We heard banging above the
dining room and the sitting room. Evidently they had taken the keys
to our trunks from General Tatishchev when they arrested him and
were removing our belongings.
Several times they asked Olga to play the piano, which was in
Commissar Yurovsky’s room. There we recognized our table linens,
on one occasion a large one with the double eagle and the crown
woven in it, and also one embroidered in the center with the double
eagle and the crown. Commissar Yurovsky also helped himself to
Father’s clothes which were much too tight and too short for him.
With all our troubles Olga became ill again with a nervous stomach
disorder and suffered excruciating pain. Mother and Father and
Marie had a small wardrobe when they first came to Ekaterinburg,
but most of their clothes were in their trunks. One misfortune
followed another in rapid succession. To add to our distress, Alexei
knocked his knee against the bed while trying to get up. At first he
fainted and after some minutes the pain became unbearable. An
internal hemorrhage caused him untold suffering, with no immediate
relief or medical help. Finally, after several letters to Yurovsky and
pleading by Dr. Botkin, Dr. Derevenko was allowed to administer
medical treatment. Mother spoke to the doctor while he attended
Alexei, but he gave no reply. The guards were at the door watching
him. He looked pale and his hands shook. When he did not respond
to Mother’s question, she realized that he was under strict orders not
to speak to us. Mother was so upset by these events that she burst
into tears. The doctor’s face turned red and he looked at her
pleadingly. He gave her some lotion, salve, clean gauze and
epinephrine as Tatiana took charge of Alexei. Dr. Derevenko saluted
and left like a shadow or a dream that comes and goes. Tatiana was
to apply the compresses of epinephrine to my brother’s knee. When
the cotton was used up, she washed the gauze and saved it, and
when that too was gone, she used Father’s old shirts or our old
blouses. For weeks Alexei suffered. He lost a great deal of weight
and became weak. Not only was his knee stiff, but this time both feet
were partially paralyzed and one leg somehow became shorter
again. Nevertheless, Dr. Derevenko was forbidden to take care of his
young patient. We were not able to use the foam apparatus. The
instruments were in a trunk in the hallway but were useless because
most of the time there was no electricity and very little hot water. This
was the only trunk that was turned over to us—because nothing was
in it that those cruel men wanted.
It became apparent that the new life we dreamed of and the new
hope that ran through us were being mocked at every turn.
Restrictions and distrust teamed together to destroy our morale. We
four sisters shared one bedroom. The first days we slept on the bare
floor covered with blankets and a conglomeration of coats and
cushions, as the house had been stripped of rugs and carpets. The
floor was cold and damp. Olga and Tatiana became so thin their
bones ached from sleeping on the hard floor. I was well padded then
and felt less discomfort than the others. After a while we received
heavy mattresses made of sacking stuffed with straw. These had to
be turned over every day creating much dust and making my
Mother’s sinus worse.
We sisters were frightened and agreed among ourselves that one of
us should keep watch at night as we had done during the last days
at Tobolsk, lying down during the day on our parents’ beds to make
up for lost sleep.
Marie described to us their treacherous trip from Tobolsk to Tiumen.
As they were crossing the Irtysh River in tarantasy, the ice, which
was many feet thick, began to break up with a thunderous noise, so
much so that even the sharpshooters and officers who were
escorting the family under Rodionov’s surveillance were frightened.
The horses struggled in the thick slush which came up to their
stomachs. Unable to raise their feet they merely pushed the slush
ahead of them. Large pieces of ice wedged between the wheels,
causing the spokes to break. In front of Rasputin’s house, a crack
like thunder was heard underneath and a huge block of ice heaved
close to them. One of the horses fell and could not get up and it took
the efforts of all the guards to lift him to his feet with the aid of a
wooden plank. What Rasputin had predicted ran through Marie’s
mind: that our family would visit his village and that our death would
follow his death. When Mother saw that Marie was frightened, she
tried to brace her up.
Horses had to be changed a number of times before Tiumen was
reached. Father, Dr. Botkin, and Prince Dolgorukov got out and
walked in the marsh to lighten the burden of the horses which were
wet, steaming and foaming at the mouth. In the evening the party
was put up at a peasant’s cottage where some tea and food was
served. Mother’s clothes were wet; she was so cold that her teeth
were chattering and her lips were blue.
After resuming their trip, Father recognized one of his generals going
in the opposite direction, dressed in peasant garb. Their eyes met.
Neither one spoke. During this trip Dr. Botkin became ill, but in spite
of that they had to continue their trip during the night, because the
river did not thaw as rapidly at night. Finally they arrived at a point
near Tiumen early in the morning.
Here part of the ice had already melted near the banks of the river,
and it became necessary for them to put up a temporary bridge in
order to cross the opening between the ice and the shore. Although
it was early in the morning—just after daybreak—all kinds of guards
were there to meet them, only a few of whom spoke Russian. The
rest seemed to be foreigners. Under a heavy escort of soldiers
armed with guns and hand grenades suspended from their belts,
they were taken to the railroad station. Here they boarded a train.
The entire party was seated in one car with Father, Mother and
Marie on one side and the others on the other side. These included
Prince Dolgorukov, Dr. Botkin, Chemodurov, Father’s old valet, Anna
Demidova and Sidniev—once a footman to us girls. The family was
not allowed to speak to any one of them.
For four whole days the train was shuttled back and forth by
Yakovlev, who had charge of the family and was sympathetic to
Father. He feared that when they reached Moscow, if Father should
refuse to comply with their demands, the entire family would be
killed. Father was puzzled at Yakovlev’s changes as to going or not
going to Moscow. But soon the family recognized that Yakovlev was
against those traitors in Moscow, but he was helpless, knowing that
Father would not leave Russia, especially not leave his family to the
mercy of these cruel men. The Germans were in control in Moscow
and Father was convinced that all orders concerning our family came
from Count Mirbach. Yakovlev’s purpose, therefore, was to forestall
this. The train itself was even set on fire in order to give the prisoners
a chance to escape. Father would not take advantage of this, as the
rest of the family would have been held in Tobolsk as hostages.
Soon thereafter Yakovlev received orders to proceed to
Ekaterinburg. They spent Palm Sunday on the train.
As they were approaching Ekaterinburg a Commissar came asking
for their papers. Father had only an identification card he always
carried in his billfold of light leather embossed with a crown in gold. It
bore his name, the date and the place of his birth, his religion and
marital status. It also indicated the issuing office: the Imperial desk.
In addition he had the identification card that had been issued to him
at Tobolsk, which contained his picture and the words: Nicholas
Alexandrovich Romanov, ex-Emperor, Citizen, Tsarskoe Selo.
In Ekaterinburg a photograph of the whole party of five was taken by
Commissars Sverdlov and Goloshchekin, both Jews. Near the
station at Ekaterinburg the people on the street went down on their
knees and kissed the ground on which my family passed. They were
guarded by the same men who came with them on the train, plus
some additional guards who now surrounded them. Upon entering
the house each gave his name and was admitted, but when Prince
Dolgorukov gave his name the Commissar said: “You are under
arrest.” This beloved friend of many years with whom Father had
played during his childhood, was now separated from them. Prince
Dolgorukov pulled out of his pocket one of his general’s epaulettes
which had been removed from his uniform in Tobolsk. He handed it
to Father and said: “It came from my Emperor and I give it back to
my Emperor.” There was no chance to shake hands. He saluted
Father and said, “God be with You, Your Majesties.” He was taken
away.... Father was so shaken by this incident, he wrote a note to
Goloshchekin, who was in charge of all prisoners, but it was fruitless.
At two o’clock in the morning a great mob of people gathered outside
the house. Several shots were fired. From the screams they knew
some were killed. The guards then entered and made a thorough
search of the house. They took Father’s money and Mother’s jewelry
and stripped all the others, including the maid, of their valuables.
Anna Demidova had all her savings with her and also jewelry given
to her by the family over the years. A foreigner who spoke to Mother
in German and to Father in French, although he understood
Russian, was insulting. It was said that he was Yurovsky’s, Trotsky’s
and Mirbach’s friend, and that he was sent to the Ipatiev House from
Moscow as a connoisseur of antiquities for a Swiss firm. His name
started with “K”. Father resented this treatment and said that up to
now he had been accustomed to deal with honest men, and that he
did not need to be reminded by a foreigner that he was a prisoner
not of his own people, but of traitors, convicts and foreign agents. It
is unbelievable that such men could come into our country and wrest
all power from the people.
The guards were Russians whose orders came from foreigners in
Moscow. Even though most of the guards were ex-convicts, they
could see the injustice that was being done. And sooner or later they
began to be more lenient. But immediately the change in their
attitude was noticed, they were replaced by new recruits.
Such was Marie’s account of their trip and stay in Ekaterinburg.
The arrival of Kharitonov, our chief cook; Trup, the valet; and Leonid
Sidniev, the 14-year-old kitchen helper, cheered somewhat the
gloomy atmosphere. When Dr. Botkin met us, he threw his arms
around us and kissed each one of us, as if we were his own children.
Tears filled his eyes. In less than a month he had greatly changed,
as had all the others.
Father’s knuckles were swollen with arthritis. His kidney condition
caused excruciating back pains. Mother’s hands too were swollen
more than before and the lump on the index finger of her right hand
was quite noticeable. She no longer could hold a needle in her
fingers. All this was due to the very difficult trip from Tobolsk and the
mental agony which persisted.
Dr. Botkin’s sad eyes forced a smile, beneath the swollen bags
under them. His pastime was limited to reading. The dear man was
anxious for news of his children, but we had none to offer, except a
few indefinite rumors we had heard on the boat. In spite of the
surrounding terrors, Dr. Botkin continued to reflect his intelligence,
kindness and tenderness. Why should dear “Papula” be punished? I
remember his children called him that. Commissar Yurovsky was
especially abusive to him, Dr. Botkin wished his children to be
brought to Ekaterinburg. He begged Commissars Avdiev and
Yurovsky to have this done but the request was denied. Fortunately,
by not coming to Ekaterinburg, they escaped the tragedy that befell
their father. This seemed so unnatural since Yurovsky was the father
of three children, and the son of a Jewish rabbi. One would think that
he would be kind to other children.
Up to now our parents had had their food prepared outside. But
when Kharitonov arrived, he resumed his duties as our cook. In the
beginning we were allowed fifteen minutes each day to walk in the
small, muddy garden; soon the grass began to show signs of life and
the fragrant lilacs began to bloom. We were permitted to take some
violets and lilacs to Mother, but they had to be examined at the office
before they were taken into our apartments. A few trees showed
considerable abuse, as the horses had chewed off much of the bark
on the white birch and poplar trees. We picked the blossoms of the
linden tree, dried them and used them to make tea. There was
always something fragrant in the garden; when the acacia was in
bloom the fragrance seeped through the windows. Sometimes
Mother went out with us in the yard, when Alexei was feeling better.
After Nagorny was taken away and when Father was ill, Dr. Botkin or
Marie carried Alexei down into the garden. One day when Dr. Botkin
carried him, Alexei threw his arms around his neck and kissed this
good friend on both cheeks in gratitude. During our walking
exercises we were subjected to the watchful eyes of the guards.
They all carried hand grenades in their belts. Some of these were
good men, but none stayed more than a few days. Once we heard
them say, “Where there are devils, there is Hell, and that is what we
have now.”
Our window panes had been painted white outside, except for a tiny
space at the top through which we could glimpse the blue sky. After
a while Father wrote Yurovsky asking him to remove enough paint so
that we could see the thermometer which was on the left side of the
window frame outside. We saw nothing but walls, prison walls.
Alexei asked Father to request that M. Gilliard be returned to us.
This too was denied. Alexei also asked Father how long we would
have to stay in this place. Father could not help but tell the truth, “It
might be long.” Alexei never brought up that question again.
Sometimes at night shots would be heard; an agonized cry, then
quiet. They searched our house again. We sisters were still without
beds. They told us to set our clocks ahead by two hours. We had our
breakfast at 12:30 noon. Kharitonov had to work not only for us and
our staff but also for these terrible men. The odors of fish and other
good-smelling things would drift to our rooms, but they were not for
us. These foods were for the Commandant and the guards. We were
given a thin fish soup or half-cooked veal cutlet at noon and a cold
one at night. Father could not eat these things, so he went frequently
without food. Mother’s meals consisted usually of spaghetti and tea,
which little Leonid prepared for her over a small kerosene burner,
because she refused to sit at the same table with those vulgar men.
The guards ate at the same table with the family. For us, it was a
question of eating the revolting stuff or starving while the guards
lived off the fat of the land at our expense.
XXIII
DEPRIVATION AND COURAGE
Every week Father was questioned in the Commissar’s room, while
the guards stood by at the doorway of our rooms. One day Father
returned very upset after being questioned for two hours. They
showed him a war document, the “Orange Book” as it was called,
from which a number of documents were missing and accused
Father of destroying these documents and substituting a letter from
the Emperor Francis Joseph of Austria, in which he wrote to Father
that he did not wish to acquire any territory, but to die in peace in his
old age. They ignored the fact that these documents had been held
at the Ministry of War after they had been read by Father and the
General Staff. Their suspicions were based on the assumption that it
was impossible for the Emperor Francis Joseph to have written such
a letter.
We had no privacy, not even the privacy of a prison. All the doors of
our rooms had been removed before we arrived at the Ipatiev
House. At any time of the day or night the guards or the
Commandant would stalk into our rooms, without knocking. This
occurred about every three hours for their check-up. The stench of
liquor that flooded the rooms warned us of their approach. They sat
on Alexei’s bed. They drank from our tumblers. They stuffed into
their pockets anything that caught their eye. They came in twos or
threes. By this time we had kept only our most treasured keepsakes,
so whatever they helped themselves to was a real loss to us. But
even precious things were worth losing if they would but leave us
alone without this constant intrusion. They kept coming in more
often, flaunting their authority in our faces, joking at our expense,
and toying with the veneer of our composure. By comparison, the
first guards at Tobolsk were gentlemen. We could not believe these
creatures were soldiers. They seemed too uncouth to have been in
any service of the Army. At night their hideous brawlings reached us
from their quarters below to fill us with disgust and terror. Dr. Botkin
tried to intercede. He went to the Commandant and urged him to see
that his men were less rowdy, but they continued to act as before.
Father seldom spoke to the Commissars. Anything he needed he
wrote down and handed it to his valet Trup to deliver to Yurovsky.
In cases of illness, Dr. Botkin took care of us on his own accord. We
sisters at home were trained not to be familiar with anyone around
us, and always to be reserved. Mother also spoke seldom to her
help, except when giving orders; and yet she was very kind to those
who were in trouble or in need. Mother was the first one to help them
financially. And now when Anna Demidova lost all her belongings
Mother promised to replace their losses to all who were in our
service.
Once when Kharitonov was ill, we sisters undertook the task of
preparing the food. One day a burlap sack of potatoes was brought
to the kitchen. “Peel them,” said one of the guards. Potatoes!
Something so real, so much a part of the earth, to hold in our hands.
We fondled each one, breathing in its earthy smell; no perfume like
it. We made a game out of paring and when we finished, there was
only a small pile of peelings. It was a refreshing task. We assumed
some of these would be for our meals, but no potatoes were served
to us. We helped on another occasion in the kitchen, baking bread.
Kharitonov was appreciative of our help, since he had lately been in
poor health, and the task of cooking for so many, commissars and
others as well as for us, was too much for him.
Twice a week two maids came in to care for our rooms. They
cleaned, washed the floors and changed our bedding. We helped
them all we could and were glad to see the new faces about. We
could not converse with them, because the guards stood at the
doorway wherever they worked. We saw their frightened faces. We
understood and they applied themselves to the execution of their
strict orders. Upon entering our rooms and again on leaving they
were searched. But somehow these women managed to tell us that
some of our friends had been imprisoned and some shot.
Now we utilized a code using verses of the Bible. While the women
worked, Mother or one of us sisters was told to read certain verses
from St. John. We hoped the maids understood that she was to
communicate with someone on the outside. The next time she came
to clean she merely raised one or two of her fingers. We thought that
someone had been interviewed and had suggested that we read
Chapter 1 or Chapter 2. Another time we understood we were
expected to read other chapters of the Bible. In that way we thought
we were in touch with someone on the outside. We did this when
conditions became dangerous. It was the only hope we believed
might save us at the crucial moment. But if any of these messages
reached anyone outside we did not know it.
We knew that food was being delivered to the house from the
neighboring monastery every other day, for our family use. However,
very seldom did any of this food reach us. The Commissars took
most of it for themselves. During our meals Avdiev sat at our table
and so did the guards. At such times the food was much better. Our
few remaining servants felt uncomfortable sitting at the same table
with us, and they asked Dr. Botkin to speak to Father about it Father
made it easier for them by saying: “We are all in the same boat, and
if we are to sink we might as well sink together.” They were
exceedingly sympathetic and showed us more kindness. We could
read the grief in their faces, but they were as brave as the rest of us.
Trup and Kharitonov were approached by Voykov to cook for them at
the club outside, a home of the Commissars. In spite of Kharitonov’s
wife and a daughter being in Ekaterinburg, both refused, and
preferred to work for their old employers without compensation. In
response to Mother’s anguished prayers, Alexei began to feel better
now. One day, Yurovsky came in and said abruptly, “Alexei is better
now. He does not need Nagorny any longer.” Poor Nagorny was
taken away. This faithful Ukrainian had done no more than serve his
young master faithfully. Also our young footman Sidniev was taken
away.
What was left of our silver disappeared gradually, except for a few
forks and spoons which we kept in our rooms. Most of our silver had
been seized from us in Tsarskoe Selo during the Kerensky regime.
Part of it was repurchased by my two older sisters from their savings
and part was purchased by Count Benckendorff who gave it back to
us.
At meal time these wretched guards monopolized the conversation
with all kinds of jokes. Their table manners were atrocious and their
appetites voracious. One of the guards leaned against Dr. Botkin to
light his cigarette from the candle which stood in the center of the
table. His sleeve got into the food, and I without a thought gave him
my napkin. The man actually looked ashamed. But as time wore on,
we thought we could notice an improvement in the attitude of the
guards. Some became tolerant and a few were even friendly. During
one of our walks in the garden one of these men spoke so that
Father could hear him say, “How cruel and senseless to hold and
abuse an innocent man.” This guard suddenly disappeared, as did
others. Every day there were new arrivals to replace those who were
being sent away, for showing sympathy for us, which no doubt
worried Yurovsky.
At night we tried to create a homelike atmosphere by lighting candles
on the table. These nourished our souls, even if the food did not
nourish our bodies. But we were told to burn one candle at a time, or
one kerosene lamp. So for a long time we did burn only one candle.
Often we were compelled to sit in the dark or go to bed early.
Electricity was off most of the time. There were promises that it
would be fixed tomorrow, but tomorrow never came and we never
saw electric lights again.
Among our household dishes, Kharitonov had a box of gold candles.
When the men searched the kitchen they became suspicious and
melted some of the candles but found nothing.
Yurovsky had an office in the house. This consisted of an impressive
desk and community bed covered with a military blanket, on which
he and others took turns resting their troubled heads. The room, dirty
and filled with cigarette butts, became a human pigsty. A samovar
graced a table, many glasses of tea were consumed. A German
newspaper rested majestically by the samovar. There was also a
pointed knife with a black horn handle, a special culinary tool with
which Yurovsky had proudly speared his cutlet at the supper table
and expertly carried it straight into his mouth, profusely decorated
with a curly, bushy black beard and mustache. In the corners of his
protruding mouth there was an accumulation of saliva which never
experienced a lonely hour. A dish with a mound of fresh butter was
replaced as soon as it was finished. We long ago had forgotten the
taste of butter. Since his last cold, the doctor had prescribed this diet
for Yurovsky’s weak chest. This brute even looked for sympathy.
The table was covered with an elegant damask table cloth with a
woven double eagle and a crown in the center. We also recognized
Prince Dolgorukov’s handkerchiefs, presumably taken away from
him during his arrest. His coat of arms displayed a hand holding an
arrow. Dolgorukov means “long arm.”
Frequently the guards asked Olga to play the balalaika or the piano,
for their amusement. Sometimes she played her own compositions.
Father could but consent so long as the pieces were not construed
to have a double meaning. Whatever the guards ordered we
complied with, thankful for an occasional moment when they
occupied themselves with something constructive. But when they
insisted that Olga sing “We Abandon the Old Regime,” she stood up
and in a firm tone said, “I will not do it, even if you kill me.” Surprised
they were at her courage. Once when she played Andante
Contabule by Tchaikovsky, they screamed “No” at the top of their
voices. “It is sad, play something else, please.” Then she played a
war song, “He Died in the War Hospital.” “No, no, please stop it; it is
sad too, play something else.” Cheerfulness they were seeking at
the hands of those who long ago had forgotten the meaning of a
happy mood. Father always stood at the doorway when anyone of us
played or sang for them. But Mother was never left alone. This habit
we had formed at Tsarskoe Selo. No matter what we did one of us
remained with her.
It had become a regular thing to search our quarters, not so much for
valuables, since by now they had already taken an inventory of
them, as for possible means of escape. Each day there was a fresh
excuse. They constantly suspected us of having something
incriminating. They heard that we had guns hidden, they would say.
No matter what the answer was, a whole troop of them would stalk
in. Each day’s experience sharpened our detective powers. We
could see without looking. Every time they stole we sensed it. We
saw them take our silver spoons, pencils, soap and other articles.
They removed everything they saw and slipped them up their
sleeves. They took apart a picture with a heavy enamel frame with
the excuse that the frame might have something hidden in it.
Underneath they found a photograph of Mother’s beloved brother
Ernest. With all the persecution she had feared to display her
brother’s photograph. So she covered it with one of our pictures.
They said nothing. Even we had not known that her brother’s picture
was hidden underneath. They also took a gold chain with an icon
which hung over Alexei’s bed. We never made any effort to stop
them, nor did we give any sign that we saw. We ignored their
thievery and curiosity since Father said: “We must not let them know
how much they annoy us; soon they will grow tired and leave us
alone.”
After much argument and after waiting for over two weeks, Dr. Botkin
was able to persuade Yurovsky to have a window opened in one of
the rooms for ventilation. They unlatched two other windows, then
accused us of unlatching them. We sisters moved our mattresses for
the night closer to that window for a breath of air. Father’s and
Mother’s beds were also moved closer to our room, where there was
only one window open, and where near by was the guard booth. We
felt sorry for Dr. Botkin, Sidniev, Trup and Nagorny. They had no
privacy. They shared the same room with doors removed and at one
end was the staircase which was used by the guards to go
downstairs. The room had two opposite doors, one leading through a
hall into one side and the other into the apartment on the other side;
Nagorny and Sidniev had been taken away in the beginning of June
before the heat became unbearable. Poor Kharitonov and little
Leonid had slept in the hot kitchen.
Our days were irregular although we arose regularly at eight in the
morning. Before breakfast we held a service and sang a prayer in
our room. Father, Mother, Dr. Botkin and all the rest joined us for a
half hour of prayer and meditation. These were the most pleasant
moments of the day, because our friends were with us at this hour.
Mother worried more about Alexei, since he had grown steadily
worse with the small amount of nourishment he had. Now all the
supply of tissue-building ingredients was gone from his diet. The
Commandant would not heed Dr. Botkin’s plea for the food
necessary to his well-being—gelatine, vegetables and fruit. The
saintly “Papula” (Dr. Botkin) begged Yurovsky to be generous to the
sick boy, but to no avail. Father also wrote to Yurovsky, but this too
was ignored by him. All this tension reacted on Mother’s heart. She
had grown much weaker and her lips, when blue, warned us of a
heart attack.
Father looked desperate, because he could do nothing to spare his
children. We knew he himself could stand anything for Russia,
anything but the persecution of his family. Only occasionally did his
hopelessness come to the surface, though he tried to disguise it from
us. With us sisters low spirits rotated from one to another. Each lived
for the other. Father knew everything that went on in our hearts and
often told us what we were thinking.
XXIV
THE NIGHTS ARE LONG
It was a sad moment when we heard that Nagorny and Sidniev had
been taken away. Without any notice they were ordered to get ready
in a few moments time. Dr. Botkin told us that both men wanted to
see us before they left. Nagorny said, “I am employed by my
Emperor and I am going to see him.” But he was rudely pushed
toward the stairway. Poor Leonid lost his only relative, his uncle
Sidniev, who had devoted his life to this little orphaned boy. Now
Leonid, the scullery boy, took the responsibility of taking care of our
dogs. It was a great treat not only to Alexei but to the family to see
someone who had been with us in Tobolsk. Leonid’s smiling face
brought some diversion to Alexei, but Leonid too was a prisoner in
the house, like the rest of us. The two boys played navy games with
toy boats and so were able momentarily to forget the existing
conditions surrounding us. Since Leonid was an orphan, Alexei’s
ambition was to give him the best possible education and care for
him as long as he would be in need.
Now that Nagorny was gone, Father himself carried Alexei down into
the courtyard for his daily airing of thirty minutes. Father’s
tenderness choked us afresh each time. All the time it was evident to
us that Father was buckling under the weight of his own injured
back. We had little heart to go out at all into a cheerful courtyard full
of heartless men. The thirty minutes airing was hardly worth the
strain on Father, but the fresh air was medicine to Alexei, until God
would answer our prayers.
We did not take the wheel chair down into the garden. Mother
wanted Alexei to walk a little each day. We took turns holding him
under the arms; his legs were so weak they would have collapsed
under him without support. Dr. Botkin thought that braces on both
legs would help. The rubber had gone to pieces on the braces he
had been using. Olga and Tatiana took stays, hooks, and other parts
of our corsets and made two braces that hooked in front. Not having
any rubber, they padded these with cotton placed between two
pieces of cloth. These proved to be effective and Alexei was able to
go outdoors wearing these braces under his trousers.
Once when we walked around the courtyard some birds made a
commotion. In my mind I wondered if they came from the Crimea.
One little fellow warbled on so eternally that we were lifted as by a
religious service. From then on we listened hungrily, each songster
seeming a harbinger of that world so shut away from us.
Now our walks were cut down to fifteen minutes. The time was so
short that it seemed we were back in the house at the moment of
leaving! Olga used to say, “Back into the vault.”
Mother seldom went out with us but, on our return, she eagerly drank
in the sweet air that still clung to our clothes. There were a few ways
left for us to amuse ourselves but these had grown monotonous. Our
books, which had been taken away from us on our arrival, were now
restored and we read them but our thoughts were far away.
Father read the Bible aloud, often starting on the page at which he
opened the book. We girls had our tapestries, but the lack of yarn
and the bad light caused us to give up working on them. Mother no
longer sewed, her eyes being bad from the inadequate light of our
lone candle. It was too much of a strain.
Alexei no longer had his toy soldiers, the guards having seized them
some time earlier. Now he passed many hours cutting out paper
soldiers with his little friend Leonid—lining them up in formation on
the squares of a chessboard. We sisters helped to design different
uniforms and color them. Anything to help the boys forget the dreary
hours. The guards leaned over the boys’ shoulders commenting on
the play.
Father wrote Yurovsky requesting a priest to come and hold a
service. After a long debate with Dr. Botkin, one of the Commissars
came at last to inform us that, on the next day, a priest would come
to hold a service in the house, the first one in Ekaterinburg. Mother
was ecstatic. We selected our choice icons and, with the help of our
friends, we put up in the sitting room a small altar, a table covered
with a hand-embroidered cloth. With the coming of the priest and the
service a little light crept into the Ipatiev House.
Just before the service began, Alexei’s bed was brought into the
room. He had been suffering from the cold as well as from swollen
hands and legs partially paralyzed from his knees down. Yurovsky
leered at us from one corner of the room but we ignored him. The
priest’s voice trembled. He was upset for fear of making a mistake,
probably knowing the fate of Father Vassiliev in Tobolsk.
It was an inspirational day; the simple ritual, the chanting, the
Communion and its consummation, our lips kissed the cross, and
our souls feasted on the Blessed Bread. Exaltation swept through us
and we soared to an enveloping oneness with God. Father read the
Holy Scripture and we all sang. What a day it was!
After the service Mother said: “The priest and the deacon seemed so
sad. Priests are in great danger these days. I pray they get into no
trouble for coming to the house.”
Did the guards feel as we felt that day? They did not interfere with
our taking Holy Communion. God’s hand was upon us and we felt
safer. The world of prison and persecution was not real. We had
glimpsed the real world, that world where our souls were filled and a
new life flowed into our withering flesh. Mother kept repeating: “The
Communion has been such a healer.”
Perhaps it was the influence of this Communion service which gave
us an inspiration. We girls put our heads together and wrote a prayer
of seven verses, one for each member of the family. We memorized
each verse completely so that we could destroy the written copy in
order to keep the prayer to ourselves. We agreed that if we were
ever separated, we could communicate with each other by using one
or more of the verses as a sort of unwritten code. We were delighted
with the idea and worked on its composition, each member
contributing. Olga put the prayer together in its final form. Then we
memorized it verse by verse. When everyone had mastered the
prayer we tore into the tiniest bits the paper on which the prayer was
written and disposed of them, a little at a time, every day. Six verses
of the prayer follow:
Our Father of all men, Giver of our lives,
In our saddest, stormy hour of this day,
We stand at the Gate of our Lord,
Give Thy courage and nourishment to our innocent bodies.
Watch over us in the hour of our fate, bathed by our tears.
Almighty Father, though men may stain their hands in martyr
blood,
Fill our hearts with forgiveness,
Grant Thy salvation to us—defenseless—
As we pray for the sickness of the souls who have gone
astray.

O, Father in Heaven, light up the land of Russia.


Enlighten her way from darkness to understanding,
Stretch Thy Blessed hand over those in need of Thy help.
Lighten their sorrows and heal their wounds.

Almighty Father, breathe into us Thy power, Thy strength;


And when the storm breaks, grant us patience.
With prayers on our lips, numb the pain in our bodies;
With compassion, close our eyes with Thy blessed hand
forever.

When we are no more, open Thy doors to the hungry spirits of


our souls.
Guide them in a prayer to be worthy of Thy Kingdom,
And grant that we may receive Thy mercy on the day of
judgment.

Blessed Father, Thou hast bestowed life upon us with the


great power of Thy hand.
Grant that, when Thou takest our lives’ spirits to be born free
again,
We may rest in peace in Thy heaven, O blessèd Father of all
men.
XXV
ACCUSATION
Yurovsky was now getting worse than ever, especially when his
men were nearby. He chose to ignore the insolence of his men when
they caught us washing our glasses after they finished drinking out
of them. Dr. Botkin again tried to intercede but, while Yurovsky
pretended to be shocked, his attitude did not change.
The maid came and whispered that Nagorny had been shot a few
days after he was taken away. She thought Sidniev too had been
shot.
The Commandants continually fabricated that Father was in touch
with the outside world, and that Father had written a letter to some
person telling him how to get into the house. Father had no
knowledge whatever of the layout of the house. From the day we
entered the premises all of us, including Father, were confined to our
quarters. We used the same stairway every time we went out or
returned. We could not even see the street because the window
panes were painted to make them opaque. We heard only the voice
of the guard on duty in front of our window, who often sang
obnoxious songs. There were two tall wooden fences surrounding
the house, but we did not know their distance from each other.
Another day, Yurovsky and Goloshchekin told Dr. Botkin that both
Father and Mother knew of an escape plot. Dr. Botkin answered
firmly it was not true. It had been suggested to us in Tobolsk, but
Father refused even to think of such a thing. Then Yurovsky said that
we had been communicating with our friends. For some time our
parents were puzzled but, after learning that every move they made
and every letter they wrote were known to the authorities in Moscow,
they realized that they were being betrayed. There was nothing
incriminating in their letters that were sent from Tobolsk through
Markov and Soloviev. They were not censored by Colonel
Kobylinsky. However, Mother complained in those letters about the
leaders selling out Russia to the enemy. She also expressed her
harsh feelings toward the traitors and the crooked foreign policy that
centered in Moscow and said that Father would stand firm no matter
what the consequences might be.
One morning Yurovsky and Voykov appeared with some papers.
After making themselves comfortable in our sitting room, they called
Father’s attention to photostatic copies of the letters that Mother had
written to Anna Vyrubova and other friends in Tsarskoe Selo and
Petrograd. There were some letters written to us from Mlle.
Fredericks and Mme. Sukhomlinova, the wife of a former Minister of
War. These were carried to and from Tobolsk by Soloviev, husband
of Matriona, Rasputin’s oldest daughter, who was selected for this
mission by Anna Vyrubova.
There were also letters purportedly in Mother’s handwriting but which
she did not write. Voykov said: “You thought Anna, Yaroshinsky,
Markov and Soloviev were your friends. We have photostatic records
of all the letters and activities in Tobolsk.” Father glanced at the
photostatic copies, recognized Mother’s and Anna’s handwriting. His
face turned white and the “Otsu mark” on his forehead became red.
To explain this “Otsu mark”: Before his marriage, Father had made a
tour around the world and, on the last lap of his journey, while in
Japan, the Emperor invited him to visit a temple where no Christian
had ever set foot before. Father rode in a ricksha, followed by Prince
George of Greece and many other rickshas. The road was lined on
both sides by the police. At the end of the line the last policeman
struck Father with his sabre on the head close to the hair line. Father
was saved by his hat, and the second blow cut his arm with which he
covered his face. At this moment Father jumped down and ran into a
store blinded with blood, still followed by the madman. Then Father
ran out of the store pursued by the would-be killer. At this moment
Prince George overtook the latter and knocked him down with his
cane. The police became confused and clashed sabres among
themselves. Fortunately the examination by his private physician
showed that the wound was not serious, but it left Father suffering
from frequent headaches and with a permanent scar. The family
called it the “Otsu scar” or “Otsu mark”.

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